---
kind: "section"
citation: "21 C.F.R. § 870.1255"
title: "21"
number: "870.1255"
heading: "Balloon aortic valvuloplasty catheter."
url: "https://uscodex.org/cfr/21/870.1255"
---

# §870.1255. Balloon aortic valvuloplasty catheter.

- (a) **Identification.** A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The device must be demonstrated to be biocompatible.
  - (2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
  - (3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
  - (4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
  - (5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.

## Notes

### Amendments

[82 FR 34852, July 27, 2017]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[82 FR 34852, July 27, 2017]